ODQ Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Several completed clinical trials evaluate conditions including mood disorders, emotional blunting, and major depressive disorder across Phase 4 and unassigned trial phases. These investigations focus on interventional research for major depressive disorder alongside the evaluation of depression assessment tools. Sponsors range from academic medical centers, such as the First Affiliated Hospital of Zhejiang University, to pharmaceutical companies like H. Lundbeck A/S.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05535270	Completed	Mood Disorders\|Emotional Blunting	First Affiliated Hospital of Zhejiang University	2022-01-01	--
NCT03835715	Completed	Major Depressive Disorder	H. Lundbeck A/S	2019-02-05	Phase 4

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the ODQ product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ODQ selectively binds to and inhibits soluble guanylyl cyclase, blocking nitric oxide-activated cyclic guanosine monophosphate synthesis to trigger pro-apoptotic pathways in target cells. This disruption of intracellular signaling sensitizes cells to apoptosis and underpins potential therapeutic interventions across studied indications such as mood disorders and major depressive disorder.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).